ISO 13485:2016 Certification | Medical Devices System

ISO 13485 is the International Standard Organization issued in 2016, representing the requirements of a comprehensive quality management system for the design and manufacture of medical equipment. This standard replaces previous documents such as EN 46001 and EN 46002 (both 1997), previously issued ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).

Although it is tailored to the expectations of the industry quality system and regulatory requirements, organizations do not need to actively manufacture medical devices or their components to seek certification for this standard, in contrast to the automotive sector of ISO / TS 16949, where only firms with active demand for quotes, or On the bid list, from international supply chain Automotive Task Force manufacturers can search for registration

Audit, certification and verification services are well known in the marketplace as a benchmark for assurance, giving you the confidence you need to access new markets and establish new business.

The ISO Strategy outlines our priorities for the next five years. It provides guidance and strategic direction, helping us to respond to a future where constant change will require us to continually improve the ISO system. It is a living document, and strategic directions are adjusted as required.

Sustainability standards and certifications are voluntary, usually third party-assessed, norms and standards relating to environmental, social, ethical and food safety issues, adopted by companies to demonstrate the performance of their organizations or products in specific areas.

There are perhaps up to 500 such standards and the pace of introduction has increased in the last decade.

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